STP938 for Solid Tumors

Recruiting at 6 trial locations

Overseen By Duc Tran

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Step Pharma, SAS

Must not be taking: Monoclonal antibodies

Disqualifiers: CNS metastases, Active malignancy, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy. The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic cancer treatments or certain investigational therapies within 4 weeks before joining the trial.

Research Team

Maureen Higgins

Principal Investigator

Step Pharma

Eligibility Criteria

This trial is for adults (18+) with advanced solid tumors that can't be cured by existing treatments. Participants must have a confirmed diagnosis, available tumor tissue for testing, measurable disease, and an ECOG performance status of ≤2. They should expect to live more than 3 months and have good organ function.

Inclusion Criteria

Life expectancy > 3 months as assessed by the Investigator

I can do most of my daily activities on my own.

My cancer can be measured by scans.

Exclusion Criteria

I have had cancer within the last 2 years.

I have an active hepatitis B or C infection.

I have active brain metastases or spinal cord issues related to cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Dose escalation of STP938 as a monotherapy with up to 5 dose levels

9 days

Multiple visits for dose escalation and monitoring

Phase 1b: Safety Expansion

Safety expansion cohort of STP938 as a monotherapy at the RP2D

6 months

Regular visits for safety and efficacy assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• STP938

Trial Overview The study tests STP938 in two phases: Phase 1a explores increasing doses to find the maximum tolerated dose as a single agent; Phase 1b examines the safety profile of STP938 at this established dose when given alone.

Participant Groups

Group I: Phase 1b (Part 2, Safety Expansion) Experimental Treatment 1 Intervention

Further evaluation of STP938 administered as oral monotherapy at the RP2D

Group II: Phase 1a (Part 1, Dose Escalation) Experimental Treatment 1 Intervention

Up to 5 dose levels with STP938 administered as oral monotherapy

Who Is Running the Clinical Trial?

Step Pharma, SAS

Lead Sponsor

Trials

3

Recruited

270+